K232154
- 510(k) number
- K232154
- Device name
- MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
- Applicant
- MiRus, LLC GA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2023-09-11
- Date received
- 2023-07-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232154.pdf
Official FDA record: K232154
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.